§1.615. What records procedures must an accreditation body have to qualify for recognition? — Inbound Citations
21 C.F.R. § 1.615
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 1.615 as a whole
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An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it meets the requirements of §§ 1.611 through 1.615. The accreditation body may use documentation of conformance with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17011:2004, supplemented as necessary, in meeting the applicable requirements of this subpart.